NOTICE
ANSM - Last updated: 04/04/2016
Name of the medicinal product
MERCRYLSPRAY, solution for pressurized bottle application
Benzalkonium Chloride / Chlorhexidine Digluconate
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
Review summary
In this notice :
1. WHAT IS MERCRYLSPRAY, solution for pressurized bottle application AND WHAT IT IS USED FOR?
2. BEFORE YOU USE MERCRYLSPRAY, solution for pressurized skin application?
3. HOW TO USE MERCRYLSPRAY, solution for pressurized bottle application?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE MERCRYLSPRAY, solution for pressurized bottle application?
6. ADDITIONAL INFORMATION
1. WHAT IS MERCRYLSPRAY, solution for pressurized bottle application AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
ANTISEPTICS (D. Dermatology)
Therapeutic indications
This medication is an antiseptic. It is used for antisepsis and cleaning of small superficial wounds.
2. BEFORE YOU USE MERCRYLSPRAY, solution for pressurized skin application?
List of information needed before taking the medication
For a good use of the medication: It is important to follow the instructions in this manual. If you are unsure, talk to your doctor or pharmacist. |
Cons-indications
Never use MERCRYLSPRAY, solution for pressurized skin application in the following cases:
· If you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6.
· If you are allergic to another antiseptic of the same family as this medication.
· In the eyes or ears.
· To disinfect medical and surgical equipment.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Precautions for use; special warnings
Warnings and Precautions
This medicinal product is for external use only.
When used on a large area, under occlusive dressing (impermeable to water and air), on a deeply burned skin, a skin of premature or infant, there are risks of passage in the general circulation .
Use with caution in newborns, especially premature infants. MERCRYL SPRAY, may cause skin burns.
Interaction with other medicines
Other medicines and MERCRYLSPRAY, solution for skin application , in pressurized bottle
· MERCRYL SPRAY should not be used together with other antiseptics because together they may irritate your skin or be less effective.
· If using soap, rinse thoroughly before applying MERCRYL SPRAY.
Inform your doctor or pharmacist if you are taking or have recently taken or may be taking any other medicines.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Do not apply solution to the breasts during breastfeeding.
If you are pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE MERCRYLSPRAY, solution for pressurized bottle application?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage / Administration
MERCRYLSPRAY, solution for pressurized bottle application is used 1 or 2 times a day, for 7 to 10 days.
The application should last at least one minute, to allow the drug to act.
Spray MERCRYLSPRAY, solution for pressurized bottle application on the area to be treated.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Possibility of contact dermatitis (redness and itching) due to the presence of chloride debenzalkonium.
Chemical burns in newborns (unknown frequency).
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE MERCRYLSPRAY, solution for pressurized bottle application?
Keep out of the reach and sight of children.
Expiration date
Do not use this medicine after the expiry date which is stated on the vial.
Storage conditions
Pressurized container: protect from sunlight and do not expose to temperatures above 50 ° C. Do not pierce or burn even after use.
If necessary, warnings against visible signs of deterioration
Do not throw any medication into the sewer or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What MERCRYLSPRAY contains, solution for skin application in pressurized bottle
The active substances are:
Benzalkonium chloride ............................................... .................................................. ........... 0.500 g
As a solution of benzalkonium chloride .......................................... ........................... 0,985 g
Chlorhexidine Digluconate ............................................... .................................................. ....... 0.200 g
In the form of chlorhexidine digluconate solution .......................................... ........................ 1.065 g
For 100 ml.
The other components are:
Citric acid monohydrate, sodium citrate, purified water.
Propellant gas: nitrogen.
Pharmaceutical form and content
Aspect of MERCRYLSPRAY, solution for pressurized bottle application and contents of the pack
This medication is in the form of a solution for skin application in a pressurized bottle.
Bottle of 50 ml.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
MENARINI FRANCE
1-7 RUE DU JURA
94633 RUNGIS CEDEX
exploiting
MENARINI FRANCE
1-7, RUE DU JURA
94633 RUNGIS CEDEX
Maker
CHEMINEAU LABORATORIES
93 ROAD OF CURRENCY
37210 VOUVRAY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this notice was revised is {MM / YYYY}
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.